So Tell Me About TSCA Reform, Part II

For an overview of the recent history of chemical regulation in America and the proposals to restructure it currently under consideration by the Senate, see my post of last Friday.

In this post, I'll get into a little more detail on how these two bills, Udall-Vitter and Boxer-Markey, deal with several of the issues at the heart of calls to reform the 1976 Toxic Substances Control Act (TSCA). As I covered in my previous post, the Udall-Vitter bill stands a better chance of being approved in something close to its current form, so I will discuss this bill in more detail.

Once again, I'm drawing on the analyses of each bill published by Bergeson & Campbell, a law firm that assists chemical firms with TSCA compliance.* In case you're interested, you can find links to full text of the two bills here.

Review of chemicals currently in use

The primary aim of TSCA was to ensure that new chemicals would be subject to careful evaluation before they were introduced into commercial use. One EPA staffer summarized the goal of the law as simply "no new PCBs."

After years of negotiations, the authors of the bill made a crucial compromise that gained them the support of representatives of chemical industry interests. Under TSCA, chemicals already in commerce as of the late 1970s would be gathered into a master inventory of "existing substances" not subject to immediate evaluation or control. They were all supposed to be reviewed eventually, but according to less stringent standards than new substances, within an unspecified timeframe.

Predictably, the EPA ended up dedicating the vast majority of its TSCA resources to fulfilling the statutory mandate that it review new chemicals immediately. Eventually, the agency developed voluntary procedures according to which chemical firms review some of the substances that they produced and used in especially high quantities. However, only very recently has the agency begun to develop a procedure for sifting through the backlog of pre-1980 chemicals whose safety has never been assessed and select those of greatest concern for evaluation.

Udall-Vitter would introduce a two-stage procedure to deal with this backlog. First, the law would "reset" the inventory of existing substances. Within a year and a half of the law's passage, firms would be required to submit the set of chemicals from this list that they had used or sold within the past 10 years. All of these recently-used chemicals would be designated as active chemicals. The EPA would work its way through the list of active chemicals, assigning them to high-priority and low-priority categories.**

Chemicals with the potential for high hazard or widespread exposure could be designated as high priority (chemicals with potential for both high hazard and widespread exposure must be so designated). Chemicals could be designated low-priority only if the EPA has "information sufficient to establish that the chemical substance is likely to meet the applicable safety standard."

Under Udall-Vitter, within seven years after a chemical is classified as high-priority, it would be subject to assessment and regulation "to ensure that the chemical substance meets the safety standard … or, if the safety standard cannot be met with the application of restrictions, ban or phase out the chemical substance." The seven-year window includes three years for completing the safety assessment, two years for writing rules, and two years of wiggle room.

Udall-Vitter also includes benchmarks for beginning to populate these lists: at least twenty chemicals must be added to each list within three years of the bill's passage, and at least twenty-five within five years. The benchmarks for completing this process, however, are squishy - the EPA is required to publish an annual goal for priority screenings and to "make every effort" to screen all active substances "in a timely manner."

Boxer-Markey takes a similar approach on an accelerated schedule, mandating that evaluations of high-priority chemicals be completed in two years, rather than three, and that fifteen chemicals be added to the high-priority list within each of the first four years after the law's passage (two to three times as many as Udall-Vitter). Furthermore, for every high-priority chemical evaluation completed, three new substances would be added to the high-priority list. (Boxer-Markey would use the cost of keeping to this schedule as the basis for setting fees on chemical companies to pay for carrying out these evaluations.)

The high-priority lists also plays a significant role in how Udall-Vitter deals with the relationship between chemical regulation at the state and federal levels - more on this below.

Testing requirements and funding

The European chemical safety framework, REACH, specifies a particular "base set" of toxicological tests to be used in the evaluation of all chemicals produced in large quantities. TSCA does not specify any such mandatory tests for new chemicals, nor does it specify any way of paying for testing.

Udall-Vitter does not add any such mandatory tests; as under TSCA, the EPA must determine that testing is necessary in a case-by-case basis. The particular tests that the EPA uses to assess chemical safety and toxicity are to be determined by the agency and reassessed on a regular basis, rather than written into the law. (I covered an apparent regulatory catch-22 related to this situation on Friday).

However, the new bill does provide a mechanism for paying for these tests. Under Udall-Vitter, the EPA would be authorized to charge chemical manufacturers and processors fees generating a total of no more than $18 million per year.*** These fees would be used to provide "a sustainable source of funds" defraying approximately 25% of the costs of enforcing the act (including chemical testing). The section authorizing these fees would expire in ten years unless reauthorized by Congress.

Boxer-Markey has no such cap on the fees that the EPA can charge to manufacturers.

Should EPA decisions pre-empt stricter state regulations?

This question is the central point of debate between the sponsors of the dueling bills. Chemical industry groups support Udall-Vitter in large part because it promises to replace the growing patchwork of state-level regulations on specific chemical substances with uniform federal standards. Boxer and Markey want to maintain the authority of states to regulate the use of chemicals more strictly - an authority that Senator Boxer's home state of California has employed particularly actively. Attorneys General of several states have echoed this defense of state regulatory authority.

Under Udall-Vitter, chemicals designated as high-priority would be off-limits to state regulation. Furthermore, if a state were to restrict any chemical not yet designated high-priority, that chemical would be subjected immediately to a prioritization screening in which the EPA could take impact on interstate commerce into consideration. A manufacturer could also request EPA screening of any chemical subject to state regulation (the manufacturer would have to pay the full cost of such screening). A chemical designated high-priority as the result of such screening would be exempt from state regulation, like chemicals already on the high-priority list.

The current language of the bill leaves an important ambiguity as to when this pre-emption of state law would take effect. It is not clear whether state restrictions would be invalidated as soon as the chemical is designated as high-priority, or only after the EPA completes its assessment and issues a rule regarding the substance. The California Attorney General's Office has noted that the former interpretation could lead to a perverse consequence in which chemicals currently regulated in some states and flagged by the EPA as potential hazards would be opened up to unrestricted use throughout the country for up to seven years.

Boxer-Markey eliminates pre-emption entirely. A plausible speculation: proponents of the Boxer-Markey bill could negotiate an unambiguous adoption of the latter effective date of pre-emption (only after an EPA rule takes effect), perhaps accompanied by more exceptions in which state-specific restrictions could remain in effect, within the framework of Udall-Vitter.

Public access to information about chemicals vs. "confidential business information" claims

Currently, there are two parts of the TSCA inventory. One is public-facing, containing information about the chemical identity of existing substances approved for use in the US. The other is a closely-held secret, containing (from the public's perspective) only generic terms for approved substances that submitting firms have claimed as trade secrets, or "confidential business information" (CBI) in the terms of the statute.

Environmental and public health advocates have criticized the relative ease with which a firm can claim a substances as CBI under TSCA. Under Udall-Vitter, each existing CBI claim would need to be reaffirmed and substantiated by the chemical firms claiming the substance as a trade secret. The EPA would be required to decide upon all of these renewed claims within six years of the passage of the law (plus two further years of wiggle room). Each approved CBI claim would be valid for ten years, though it could be renewed if the ongoing significance of the substance's confidentiality could be demonstrated.

Udall-Vitter also deleted a rather draconian provision in a 2013 version of the bill mandating that an EPA employee be fired for an improper disclosure of CBI, even by accident.

Asbestos, cost-benefit analysis, and safety standards

As I described in Friday's post, the 1991 federal court decision invalidating the EPA's attempt to ban asbestos under TSCA is often taken as the signal failure of the law. In overturning the EPA's decision, the judge ruled that the ban failed to satisfy the act's stipulation that any control measure imposed on an existing substance involve the "least burdensome requirements" necessary to alleviate a definite "unreasonable risk."

A previous reform proposal had introduced cost-benefit analysis throughout as a flexible means of assessing how "burdensome" a given regulatory measure might be in any given case. Udall-Vitter explicitly excludes cost-benefit analysis from determinations of safety. In light of the asbestos episode, it is worth quoting the bill's definition of safety in its entirety:

The term ‘safety standard’ means a standard that ensures, without taking into consideration cost or other nonrisk factors, that no unreasonable risk of harm to health or the environment will result from exposure to a chemical substance under the conditions of use.

The bill goes on to specify that "unreasonable risk" includes both risk to the general public and to any particularly exposed or susceptible group.

However, in deciding what to do about a risky chemical - that is, what control measures to enact - Udall-Vitter specifies that cost-benefit analysis be applied. In other words, under Udall-Vitter, epistemically, safety is not a function of cost, but pragmatically, it is.

Boxer-Markey excludes cost-benefit analysis from rule-making except when a rule is likely to have an economic impact of more than $100 million. It also fast-tracks asbestos and persistent bio-accumulative toxins (PBTs) for assessment and control.

Loopholes

Under Udall-Vitter, various circumstances can exempt a chemical or product containing it from normal assessment and control procedures. For example, the EPA may exempt replacement parts containing a regulated substance from controls on that substance, as long as the object whose parts are getting replaced predates the regulation.

Udall-Vitter would also authorize the EPA to exempt particular uses of a substance from general EPA regulations on that substance in cases in which the strict enforcement of the law would

harm national security

significantly disrupt the national economy

interfere with a critical or essential use for which no feasible safer alternative is available

interfere with a substantial benefit to health, the environment or public safety

Come on: toxic chemicals, nefarious capitalists, fire-breathing environmentalists, tear-jerking stories of chronic illness, the dismantling of American industry, and all we get is a breakdown of legislative minutiae?

2
comments

I work in the regulatory affairs department of a French company which makes business in the US and, therefore, I am interested to know more about the TSCA reform so the company will be able to anticipate the TSCA changes in order to continue to have its products in compliance with the American chemical legislation and,therefore, I would like to know if you could answer me this questions:

1- I would like to know how the EPA would, precisely, determine if a chemical meets the 'safety standard' ? There would be tests to determine whether the definition of 'safety standard' is met? 2- Among the products that the companies have sold more than 10 years ago, which ones of them will be on the list of active chemicals?3- Cost-benefit factors may be considered for the chemicals assessment procedure? And for eventual control or regulatory measures?4- The exemption categories of chemicals will remain the same? There will be new categories of exempted chemicals? 5- What will be the new legal procedure to allow EPA to request assessment of a chemical? The agency is still obliged to prove that the chemical is hazardous?6- Once the active chemicals list is composed, what will happen with the TSCA inventory? A chemical that is currently listed TSCA and that is classified high-priority, will remain listed as long as its assessment is not done yet or the TSCA inventory will be reseted?7- The requirement of 25 high priority chemicals and 25 low priority chemicals in 5 years of enactment means that in 5 years only 50 chemicals will be evaluated ? And what will happen to the chemicals on the active chemicals list that have not been evaluated yet but were listed TSCA, they will be able to be put in market or we will be obliged to wait their assessment? 8- In which way the new procedure of assessment for new chemicals is different? Will it be more rigorous?9- In the current TSCA bill is there any particularity on the assessment and notification of chemicals in articles?10- The requirement of making a Chemical Data Reporting (CDR) every 4 years will be remained?

Thanks for your questions. It's hard to give good answers to any of these right now, as the US House of Representatives has passed one version of the bill and the Senate is considering a different version. Each bill answers these questions in different ways. If the Senate passes its version, then the two will have to be reconciled - once that happens, it will be possible to answer some of these questions definitively.

For more information on the two bills, I have found these analyses to be most useful. For the House bill: http://www.lawbc.com/regulatory-developments/entry/tsca-reform-house-passes-tsca-modernization-act-senate-to-consider-tsca-sooandhttp://www.lawbc.com/regulatory-developments/entry/tsca-reform-detailed-review-of-the-tsca-modernization-act-of-2015-considere

For the Senate bill: http://www.lawbc.com/regulatory-developments/entry/tsca-reform-detailed-analysis-of-substitute-version-of-frank-r-lautenberg